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Postscripts November 201 3

Volume III Issue 1 9 November 201 3


In this issue: • Not the Smartest Pencil in the Cup


(What Not to do with an IB) • Spotlight on GAPP • What do Journal Editors do

Official publication of the American Medical Writers Association Pacific-Southwest Chapter

Š Chip Reuben 2008

AIMS AND SCOPE Postscripts is the newsmagazine of the American Medical Writers Association Pacific-Southwest (AMWA Pac-SW) chapter. It publishes news, notices and authoritative articles of interest in all areas of medical and scientific writing and communications. The scope covers clinical/regulatory writing, scientific writing, publication planning, social media, current regulations, ethical issues, and good writing techniques.

MISSION STATEMENT The mission of Postscripts is to facilitate the professional development of medical writers and serve as a tool to advance networking and mentoring opportunities among all members. Towards this mission, Postscripts publishes significant advances in issues, regulations and practice of medical writing and communications; skills and language; summaries and reports of meetings and symposia; book and journal summaries. Additionally, to promote career and networking needs of the members, Postscripts includes news and event notices covering Chapter activities. EDITOR

Ajay K Malik, PhD

SUBSCRIPTION Postscripts is published monthly except in January and July. Subscription is included in the AMWA Pac-SW chapter membership which is automatic for all AMWA members with a mailing address in Southern California, Southern Nevada and all of Arizona. This newsmagazine is distributed on the 1 st of each month. AMWA members can request past issues by sending an email to the editor.

INSTRUCTION FOR CONTRIBUTORS We welcome contributions from members and non-members alike. Please contact editor.

ADVERTISING Articles describing products and services relevant to medical writers may be considered or solicited. Members may submit advertisements for their services or products for free. Please contact editor for details.


Jenny Grodberg, PhD, RAC President, AMWA PacSW

Postscripts Website:

Chapter Website:

Find Us On LinkedIn:

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American Medical Writers Association Pacific Southwest Chapter (AMWA Pac-SW) San Diego, CA Copyright 2011 -201 3, AMWA Pac-SW All rights reserved. (Authors retain copyright to their articles.)

Banner Photo Art by Chip Reuben, / Red phone booth. By Petr Kratochvil,


POSTSCRIPTS November 201 3 | Volume 3, No. 1 9

1 53. From the President's Desk — Jenny Grodberg, PhD, RAC 1 54. Not the Sharpest Pencil in the Cup — MaryAnn Foote 1 59. Spotlight on GAPP — Jennifer Reichert, PhD, CMPP 1 64. Of Humans and Genomes — Mira Sastri, PhD 1 57. What's UP(!). . . at FDA — Sally Altman and Kelly Dolezal 1 58. What's UP(!). . . at EMA — Wim D’Haeze

COVER: Golden Lake, Renfrew County, Ontario. By Mathew Ingram via Flickr. 8/ , used under CC BY license.

1 60. AMA-zing Style — Dikran Toroser, PhD 1 62. de-MS-tifying Word — Susan Chang, PhD, and Alyssa Wu-Zhang, PhD 1 56. Interview Tips and Tricks with Peggy Wallace — James Sanchez, PhD 1 63. Safety Sentinels: Pharmacovigilance Issues and News — Ellen Klepack, PharmD 1 66. Backpage : The History of AMWA UPCOMING EVENTS AND DATES November 6-9, 201 3 : AMWA Annual Conference, Columbus, OH . November 1 9, 201 3 : Donna Simcoe – Publication Planning, a tcon/webinar presentation . December 7, 201 3: Holiday gathering – Jacki Dyck-Jones, Thousand Oaks, CA. **See page 165 for conference calendar

CHAPTER CONTACTS President: Jennifer Grodberg, PhD, RAC, Immediate Past President: Noelle Demas, MA, Treasurer: Valerie Breda, MA, Arizona Liaisons: Kathy Boltz, PhD, az-liaison-1 Mary K Stein, PhD,

Membership Coordinator: Gail Flores, PhD, Employment Coordinator: Irene Yau, PhD, Website Communications : Mary (Mimi) Wessling, PhD, Postscripts Editor: Ajay Malik, PhD, Asilomar Conference Chairs: Sharon Dana, PhD, & Jenny Grodberg, PhD POSTSCRIPTS | VOL 3, NO. 1 9 | NOVEMBER 201 3

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From the President's Desk Greetings AMWA friends and colleagues,

Tummies filled with Halloween candy, we eagerly look forward to feeding our appetite for knowledge and networking at the bountiful AMWA annual conference offerings in Columbus, November 6-9. Those seeking food and drink along with nourishing (re)connections are welcome to join the Chapter dinner outing Thursday evening….last-minute signups are ok! Next course will be served November 19. The hostess, Donna Simcoe, will offer an informative on-line session on Publication Planning. Registration details to follow soon! And don’t forget the year’s AMWA Pacific Southwest Chapter dessert: our holiday at Jacki Dyck-Jones’ beautiful home in Thousand Oaks, CA. Looking forward to Jacki’s warm and inviting hospitality! The first course, of course, is this month’s newsletter, filled with tasty nuggets of insight and engaging information. A special thank you to Mira Sastri for her “Of Human and Genomes” special feature as well as to James Sanchez for his review of the October 5th “Interview Tips and Tricks”, a well-received, invaluable session. led by Peggy Wallace. Plus a huge THANK YOU to the wonderful contributors who regularly nourish our minds with their engaging columns. Our Chapter will be serving an updated menu starting early 2014. I am thrilled to announce that Donna Simcoe has agreed to be our next Chapter President, and Elise Sudbeck will be our new treasurer. Donna Simcoe is Publications Director at Cadence Pharmaceuticals, with previous publication experience at AstraZeneca, Wyeth and Cephalon. Donna holds an MS in Biomedical Writing, an MS in Biotechnology, an MBA, and is a Certified Medical Publication Professional (CMPP). She has given many presentations about publication development and chaired CBI’s 8th Annual Forum on Strategic Publication Planning Meeting in December 2012. In addition to AMWA, she has been actively involved with the International Society of Medical Publication Professionals (ISMPP), The International Publication Professionals Association (TIPPA), Biocom and Oxbridge Biotech. Donna currently serves as the chair for the ISMPP U committee (monthly webinars for medical publication professionals, 2013-2014). Elise Sudbeck had been a medical writer for 8 years, currently serving as Principal Regulatory Writer at Ardea Biosciences in San Diego. She has lived in San Diego for 11 years and joined AMWA in 2006. Elise holds a PhD in Chemistry and has completed the Clinical Trials Design and Management certificate offered through UC San Diego Extension Program. We look forward to the energy and new flavors Donna and Elise, together with our other Chapter leaders Jacki Dyck-Jones, Gail Flores, Ajay Malik, Irene Yau, Kathy Boltz and Mary Stein, will bring in the coming year. Stay tuned! Wishing all a joyous and bountiful Thanksgiving holiday. Warmly,

Jennifer Grodberg, PhD, RAC President, AMWA Pacific-Southwest Chapter

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Not The Sharpest Pencil in the Cup MaryAnn Foote This month, I thought I would take a different approach to a problem, providing several not-so-sharp scenarios covering the investigator’s brochure (IB). As always, I have tried to conceal the identities of people/companies/regional areas. First of all, a quick review what is an IB and what is its role in clinical development: Marketed drugs and biologics have package inserts or package leaflets (depending on the country) and these materials are considered to be labeling. Products in the preapproval stage do not have package inserts or package leaflets, but the sponsor is required to summarize what is known about the product characteristics and nonclinical and clinical information (if any) for investigators of a clinical trial. Thus, the IB; it contains all that is known about the product, how it is being studied, and often what new nonclinical indications are in the works. As an aside -- The information in the IB must be readily available and focus on details critical to safety of subjects enrolled in the clinical trial. Most IB in the United States, Canada, European Union, and Australia average about 50 pages. Japan has different requirements and more information is needed yielding a larger IB. The purpose of an IB seems clear, it is labeling for an investigational product, but in 20+ years of experience, I have seen/heard/read about various problems with IB and offer some candidates for our Not the Sharpest Pencil in the Cup Award:

1 . The IB is Not a Sales and Marketing Tool – Global Company S numbers all copies of its IB for all products and keeps a master list of which numbered copies are sent to whom and when. Quite a time-consuming enterprise but it allows Company S to quickly replace IB with updated versions. A sharp-eyed assistant noted that an office in another country was ordering far more IB than it had clinical sites. Even accounting for

IEC/IRB and general office use by employees of Company S, the ongoing orders for more copies was alarming. Further investigation revealed that the Sales and Marketing Teams were handing out IBs at every sales call, conference, or meeting, often leaving them behind on coffee tables in physician’s waiting rooms.

2. The IB is Highly Confidential -- An IB is the

label for an investigational product, providing basic chemistry and all that is known about it, both nonclinically and clinically. It was quite alarming when the corporate headquarters of Company B received an IB from an unknown person who had mailed it in a plain brown envelope postmarked from a city where a large international meeting had just convened. Obviously, the person who mailed the IB to Company B knew the significance of the document and Company B was left wondering if a photocopy had been made before it was kindly sent back.

3. The IB is not a 2-Volume Set – The IB

(omitting Japan from discussion here) should be a living document. The first version of an IB will focus heavily on nonclinical data because no humans have been treated. As clinical data are available, the nonclinical data should be summarized (tables are particularly useful) and more emphasis placed on new and significant clinical data. Academic clinicians at a small start-up Company H refused to summarize any data and the freelance writer hired to prepare the updated IB was confronted with a 500-page, 2-volume set. The writer tried to explain to Company H that the IB was too cumbersome to be of use to an investigator, there was no mechanism to ensure that both volumes would

(continued on next page)


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be kept together, and the volume of the IB pages would make it difficult for investigators to find critical information, compromising patient safety. Summaries were finally agreed to, bringing the IB down to 1 volume of about 300 pages. Small print.

4. The IB is Your Product’s Label Only – The

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While many temptations exist for extracurricular activities for your IB, it is best to consider the purpose of the IB and strictly limit its use to such a purpose. What experiences have you had with the IB? Do you have any other candidates for Not the Sharpest Pencil in the Cup?

Colored Pencils by Petr Kratochvil via publicdomainpictures

freelance writer for Company H also tried to convince the clinicians at Company H that it would not be prudent to include information about marketed products from other companies in Company H’s IB. (Often a marketed product is given during a clinical trial to minimize or eliminate known side effects.) The writer argued that it would be better to use a generic name, not a trade name, and to suggest that the investigators refer to the current package insert of the marketed product for correct dosage. The writer lost this battle, too. As would be expected, as soon as Company H sent out its IB, the marketed product it had referenced by

trade name had a significant label change, and Company H was required to recall, rewrite, print, and mail out their updated IB very quickly. The exercise was an expensive and delaying one for the small company.


Meeting Report

Interview Tips and Tricks with Peggy Wallace By James Sanchez, PhD

University of Southern California, Los Angeles

converse shoes (modified) by kirstiscott,

AMWA-PacSW members and guests had the pleasure of attending a lunch and a seminar featuring Peggy Wallace, founder of Making Conversation, LLC, on October 5 th in Carlsbad, California. After the delicious meal, Peggy gave the audience part of her strategy for landing that coveted position. Peggy upheld that, in this age of e-mails and social media, there is still no substitute for real human contact. We illuminate ourselves by what we say, and how we say it. Peggy suggested that you remain standing in the waiting room in the moments leading up to the interview, because when it’s time for you to say hello to your interviewer, who looks good scrambling out of a seat? As you shake hands, be close enough that your elbow has a relaxed bend. A stretched-out arm might suggest aloofness. But you should also resist using your other hand to cover the handshake. Your interviewer might interpret the gesture as overly intimate – or even controlling. During the interview itself, try to motion with your hands to underscore your points and inspire some enthusiasm in what you are saying. As for what you actually say, Peggy pointed out that you neither want to be too timid talking about your

accomplishments, nor too boastful. It won’t do to say “I was, sort of, the [your amazing last position]”. Your interviewer is also not a mind reader, so if you want to impart, for example, that you are flexible, you need to actually say that you are flexible. To avoid a self-congratulatory attitude, you may wish to modestly put that you were a member of a great team, or that you were fortunate to achieve what you set out to do. After all, what potential employer doesn’t want a lucky person on the team? Peggy likened an interview to a piece of real estate: There is a limited amount of it, so be careful how you use it up. Do not waste precious time telling the interviewer things he or she already knows. And if the conversation takes a turn toward your mutual love of sailing, try to steer the topic back on track, or your interview might become entirely about sailing! It is a good idea, Peggy explained, to use hard facts and figures to illustrate your background. They are something solid to “hang your hat on,” she said. A salesperson, for instance, will score points listing a concrete percentage rise in sales over a particular time period. And for less-than-wonderful events, like a layoff, do not pretend that you were overjoyed but instead talk plainly about what happened. (For example, how many people were laid off, when, and why?) After the interview is over, Peggy recommends sending both an e-mailed “Thank you” and a more traditional thank you card. These should be sent to everyone who took part in your interview. When it comes to social media, Peggy has reservations about how many meaningful relations are formed that way. As her talk highlighted, it is the human, real-world connections that truly leave a lasting impression. POSTSCRIPTS | VOL 3, NO. 1 9 | NOVEMBER 201 3

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What's Up(!) . . . at FDA By Sally Altman and Kelly Dolezal

During the past month, several companies voluntarily recalled pharmaceutical products as a result of contamination. Additionally, two new drugs for hypertension, and one for major depressive disorder were approved.

FDA Announcements 1 0-1 9-1 3

A Michigan compounding pharmacy voluntarily recalled all lots of some of its unexpired human and veterinary sterile products as a result of the discovery of particulate matter in a compounded dextrose injectable product. Specialty Medicine Compounding Pharmacy indicated that no adverse events had been reported as a result of the contamination. 1 1 0-1 8-1 3 Hospira voluntarily recalled one lot of bupivacaine HCL injection following a confirmed customer report of particulate matter inside the product’s glass vial and embedded in the vial’s glass. No adverse events have been reported as a result of the contamination. 2 1 0-1 5-1 3 B. Braun Medical voluntarily recalled one lot of Cefepime after visible organic particulate matter was found in a reserve sample. No adverse events have been reported as a result of the contamination. 3 1 0-1 0-1 3 As a result of internal monitoring, Nephron Pharmaceuticals Corporation voluntarily recalled some lots of albuterol sulfate inhalation solution. All affected lots passed the company’s quality specifications at the time of manufacture, and the recall was described as a precautionary measure. 4

Selected FDA Approvals Drug Indication Opsumit5,7

Guanylate cyclase stimulator for the treatment of chronic thromboembolic pulmonary hypertension to improve exercise capacity in adults. Treatment for pulmonary arterial hypertension in adults.


Treatment of major depressive disorder (MDD).



Bayer Healthcare Pharmaceuticals Actelion Pharmaceuticals Takeda Pharmaceuticals

For additional information, including labeling revisions, tentative approvals, efficacy supplements with supporting clinical data, manufacturing changes or additions, or chemistry; new strength, see 1 436.htm

[Link] [Link] 3 030.htm [Link] 4 51 .htm [Link] 5 [Link] 6 362.htm [Link] 7 362.htm [Link] 8 6.htm [Link] 2 41 2.htm

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What's Up(!) . . . at EMA By Wim D’Haeze EUROPEAN MEDICINES AGENCY (EMA) ALERTS (25 SEP 201 3 THROUGH 25 OCT 201 3)

The alerts listed below cover the period from September 25, 201 3 through October 25, 201 3. Only key alerts thought to be of interest to the AMWA community were included; for additional updates and details refer to What’s New on the EMA website.


• None to rreport

REPORTS/PAPERS • Meaning of the black trianglea APPROVALS/REFUSALS Compound Indication/Use


Advice [Note]

Levetiracetam Monotherapy in the treatment of partial onset Hospira UK Limited Positive opinion b Hospira seizures with or without secondary generalisation in adults and adolescents from 1 6 years of age with newly diagnosed epilepsy. Brintellixc Positive opinion Treatment of major depressive episodes in H. Lundbeck A/S adults d Opsumit Opsumit, as monotherapy or in combination, is Actelion Registration Ltd. Positive opinion indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III Note: “positive” or “negative” opinion indicates the Committee for Medicinal Products for Human Use (CHMP) adopted a positive or negative opinion in regards of granting the marketing authorization, respectively, awaiting a final decision of the European Commission (EC).


• Improved GMP-related information exchange between EU and Japan. e • European Medicines Agency begins to publish recommendations based on safety signals. f


EMA Website - What's New: _events/landing/whats_new.jsp&mid=WC0b01 ac058004d5c4 [Link]

d. es/human/medicines/002697/smops/Positive/human_smop_00 0608.jsp&mid=WC0b01 ac058001 d1 27 [Link]

a. n_document.jsp?webContentId=WC5001 50608 [Link]

e. nd_events/news/201 3/1 0/news_detail_001 908.jsp&mid=WC0b0 1 ac058004d5c1 [Link]

b. s/human/medicines/002783/smops/Positive/human_smop_0006 02.jsp&mid=WC0b01 ac058001 d1 27 [Link] c. s/human/medicines/00271 7/smops/Positive/human_smop_0006 01 .jsp&mid=WC0b01 ac058001 d1 27 [Link]

f. nd_events/news/201 3/1 0/news_detail_001 907.jsp&mid=WC0b0 1 ac058004d5c1 [Link]


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Spotlight on GAPP, the Global Alliance of Publication Professionals! By Jennifer Reichert, PhD, CMPP The Global Alliance of Publication Professionals (GAPP) was launched in January of 201 2 to “bridge the gap between journalists and medical publication professionals.” GAPP aims to provide timely responses to stories in journals, mainstream media, and social media, which affect medical publication professionals. GAPP’s ambitious goal is to respond to significant articles pertaining to publication professionals and practices within 24-48 hours. GAPP responses reinforce the value and ethics of publication professionals. GAPP is led by five volunteers from Europe, North America, and the Asia-Pacific region. GAPP members are publication professionals with leadership positions in ISMPP, EMWA or AMWA. GAPP is also a resource for those needing timely input from international leaders of medical publication professionals. A frequent topic of GAPP responses to news and journal articles is the difference between professional medical writers and ghostwriters. The topic of ghostwriting continues to appear with regularity in news and journal articles and GAPP responses are definitely worth a read.

The GAPP website also includes links to medical writers associations around the world, a list of key references on the role of publication professionals, and biographies of the members.

GAPP has had several articles published in highranking peer-reviewed journals, mainstream media, and social media. A select list of GAPP publications is provided below. The complete list can be found at

1 . Hamilton CW, et al. Exorcising Ghosts. Lab Times. 201 3 Mar; page 1 0. 0al%20exorcising%20ghosts.pdf 2. GAPP Submission to UK Parliamentary Inquiry on clinical trials. 6 March 201 3. K%20Parliamentary.pdf 3. Jacobs A. The ethics and value of professional medical writing assiatance. Endocr Pract. 201 3;1 9(2):2-3. 20Statement%20Endocrin.pdf 4. Gertel A, et al. The Global Alliance of Publication Professionals: Update on a Small Group with a Big Mission. AMWA J. 201 3;28(1 ):42-44. TABLE

6-Mar-2-1 3 GAPP applauds Marcus and Oransky for considering challenges of determining authorship and defines "substantial contribution." [Ref.1 ] 6-Mar-2-1 3 GAPP makes a comprehensive, evidence-based submission to the UK Parliamentary Inquiry on Clinical Trials, stressing how professional medical writers can help address publication problems. [Ref.2] 6-Mar-2-1 3

GAPP challenges ACRE statements about medical writers and gains recognition from ACRE about the value and integrity of professional medical writers. [Ref.3] Jan - 201 3 GAPP describes its mission and its accomplishments during its first year. [Ref.4]

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AMA-zing Style — the AMA Manual of Style Column By Dikran Toroser, PhD, Amgen Inc.

JOURNAL EDITORS What do journal editors do? It is important for a medical writer to be familiar with the role of this powerful individual. The AMA manual of style has useful content on pages 260-275 and dispersed throughout the volume on this subject.

Editorial Responsibilities, Roles, Procedures, and Policies . Together with the authority that comes with editorial freedom are responsibility and accountability. Editors are responsible for determining the journal’s content, ensuring the quality of the journal, directing editorial staff and board members, developing and maintaining procedures.

The Editor's Responsibilities . An editor's

primary responsibilities are to inform and educate readers and to maintain the quality and integrity of the journal. Thus, editors are obliged to select papers for publication that are appropriate for their readers and maintain standards. The editor's duty to readers often outweighs obligations to others with vested interest in the publication and may require actions that may not appear fair or suitable to authors, reviewers, owners, publishers, advertisers or other stakeholders. You may appreciate that it is often not a popular role! The AMA manual identifies some important requisites for the editor role: competence, fairness, confidentiality, expeditiousness, and courtesy. Editors must possess a general scientific knowledge of the fields covered in their publications. A competent editor will also be skilled in the art of rhetoric and identify and remove hyperbole, inconsistent arguments, and unsupported assertions and conclusions from manuscripts.

Conflicts of Interest. Editors should not have financial interests in any entity that might influence editorial evaluations and decisions. Editors with other types of conflicts of interest with a specific manuscript or author that could impair objective decision making should remove themselves from involvement with such papers and should delegate responsibility of the review and decision of such papers to another editor or editorial board member. Confidentiality. Editors must ensure that information about a submitted manuscript is not disclosed to anyone outside the editorial office, other than the peer reviewers and authors invited to write an editorial commenting on an accepted but not yet published manuscript.

Editorial Responsibility for Acceptance

Acceptance. Editors should follow consistent procedures to evaluate papers and make decisions regarding acceptance. Editors should inform authors of acceptance of their manuscripts in a letter that describes the subsequent process of publication, including substantive editing and any remaining queries: editing of the manuscript, tables, and figures for accuracy, consistency, clarity, style, grammar, and formatting. Provisional Acceptance. Some editors use provisional or conditional acceptance for revision requests when they are fairly certain that the revision will be accepted for publication. However, use of a provisional acceptance as a request for revision can cause problems if the (continued on next page)


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revised manuscript is not suitable for publication. To avoid such problems, provisional acceptance decision letters should clearly communicate that acceptance is contingent on specific conditions.

Editorial Audits and Research . Many journals

conduct internal audits. For example, a journal may produce reports from its database of manuscripts, authors, and peer reviewers to track inventory, workflow, and efficiency metrics. Trends from these reports can help editors determine the number and types of papers to accept for publication, assess staffing needs, track reviewer performance, and determine when to institute corrective action. JAMA publishes an annual editorial audit that includes the number of manuscripts received the previous year, acceptance rates, and the turnaround time for manuscripts that are reviewed, accepted or rejected and published.

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See pages 260-275 and throughout the volume of the AMA manual 1 0th edition for further information, as well as pages 2-20 of a white paper by the Council of Science Editors at: entire_whitepaper.pdf

de-MS-tifying Word By Susan Chang, PhD, Susan Chang Consulting and Alyssa Wu-Zhang, PhD Weary writers, what are your Word woes? Let us know! Below is a recap of past “de-MS-tifying Word” articles and URLs (if available). Ideas for upcoming articles include: 1 ) how to view, create, and modify Styles; 2) creating and modifying Headers/Footers; 3) best practices for Figures; and 4) best practices for Tables.

What would you like to see? UPDATES: We listen to your requests! This year we’ve expanded to include instructions for Macs, and soon the PC content will cover MS Word 2007 through 201 3. (As soon as Susan’s new laptop arrivesV)

PostScripts Date Column Topic(s) Volume, Issue May 201 2 Vol 2, Issue 3

Jun 201 2 Vol 2, Issue 4

Nov 201 2 Vol 2, Issue 9 Dec 201 2 Vol 3, Issue 1 0 Feb 201 3 Vol 3, Issue 11 Mar 201 3 Vol 3, Issue 1 2 Apr 201 3 Vol 3, Issue 1 3 May 201 3 Vol 3, Issue 1 4 Jun 201 3 Vol 3, Issue 1 5 Aug 201 3 Vol 3, Issue 1 6 Sep 201 3 Vol 3, Issue 1 7 Oct 201 3 Vol 3, Issue 1 8


Shortcuts for navigating long documents


Track change user name and initials to facilitate reviews/revisions Automated features for numbered and alphabetical lists Track change settings and tips for facilitating document reviews View, navigate, and troubleshoot formatting problems Formatting shortcuts, international characters, and autocorrect options Captioning (tables, figures) and cross referencing (tables, figures, section headings) “Safe Paste” options for importing text from other sources Creating customized, electronic tables of content (TOCs) The mysterious section break: Next page and continuous section breaks Optimal view settings and synchronous scrolling to compare two documents Advanced formatting features: Window/orphan control, Keep with next, Keep lines together, and Page break before

N/A N/A 0 2 3 4 5 6 7 8

Word woes?

Email us at (PC) and (Mac). POSTSCRIPTS | VOL 3, NO. 1 9 | NOVEMBER 201 3

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Safety Sentinels: Pharmacovigilance Issues and News By Ellen Klepack, PharmD This month’s column will feature H.R. 3204 The Drug Quality and Security Act. Drug Supply Chain Security Act

The Drug Quality and Security Act was passed by the U.S. House of Representatives on September 28, 201 3 and will go the Senate for a vote. Two components were coupled together in this bill and both pertain to drug safety. The first component allows for greater FDA oversight of compounding pharmacies and is in response to last year’s deadly outbreak of spinal meningitis due to tainted steroid injections made at the New England Compounding Center in Framingham, Mass. The second component addresses drug supply and aims to secure the national drug supply from counterfeit drugs. Both components are summarized below.

Compounding Quality Act

The Drug Supply Chain Security Act will create a national electronic database to track and trace drugs from manufacturer to pharmacy in an effort to keep counterfeit medications out of the drug supply. This legislation replaces current drug tracking methods, which consist of a “patchwork” of state laws. Tracking will start at a lot level in January 201 5 and transition over a 1 0 year span to electronic tracking on a unit level. Drug serial numbers will be established nationwide four years after the date of enactment, allowing the industry to better respond to recalls, notices of theft and counterfeiting. Additional items included in the legislation are a strengthening of licensing requirements for wholesalers and third party logistics providers and the creation of a database on FDA’s website of appropriately licensed wholesalers that will be made publically available.

The Compounding Quality Act will create a national set of standards and give FDA greater authority to oversee and inspect large scale compounding pharmacies. Large scale compounding pharmacies (i.e., pharmacies that ship bulk compounded product to hospitals and doctors’ offices) will voluntarily be able to register as an “outsourcing facility”. Once registered, the FDA can obtain information about what products are being made at the facility, receive adverse event reports on compounded drugs and provide risk-based inspections. A list of FDA-regulated outsourcing facilities will also be created and made publically available on FDA’s website. Traditional compounding pharmacies (i.e., pharmacies that compound medications based on a prescription for specific individuals) will not be affected by this legislation and will continue to be regulated by State Boards of Pharmacy. This legislation should afford providers more confidence when purchasing products from large scale compounding pharmacies as they will be able to choose companies that are registered as outsourcing facilities and subject to FDA quality standards.

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1 . Upton F. H.R. 3204, The Drug Quality and Security Act. Washington, DC: Energy and Commerce Committee; September 27, 201 3. Accessed October 1 7, 201 3. 2. HELP committee members call for Senate passage of Drug Quality and Security Act [press release]. Washington, DC: US Senate Committee on Health Education Labor & Pensions; September 28, 201 3. 50-6a23-454e-a60c-09643348c6e0. Accessed October 20, 201 3. 3. Clarke T. US congressional panels agree on bill to regulate drug compounding. Reuters Web site. 3/09/26/us-compoundingpharmacies-legislation-idUSBRE98P00B201 30926. September 25, 201 3. Accessed October 1 7, 201 3. 4. HR 3204, 11 3 th Congress, 1 st Sess (201 3). 3hr3204eh/pdf/BILLS11 3hr3204eh.pdf. Accessed October 1 7, 201 3.

Of Humans and Genomes By Mira Sastri , PhD

University of California San Diego, La Jolla, CA Paraphrasing Gertrude Stein: A man is a man is a man. Or is he? That is the question philosophers have pondered for a long time, and now scientists are contemplating the same questions by looking at variations at the genomic level. Science and crime dramas constantly reiterate that the genetic code is the fingerprint that reveals each individual’s identity. However, with recent advances in genome-wide sequencing, scientists are reevaluating long-held tenets of the “personal” genome wherein each cell was assumed to harbor the same genome. Instead, each cell has its own unique genome; this phenomena- known as mosaicism-has been explored in a series of articles by a number of researchers, and highlighted in a recent New York Times article: DNA double take by Carl Zimmer.

genetic mosaicism) that helps us combat host of pathogenic bacteria and viruses. Another example is when genomes of fetuses undergo spontaneous mutations to heal damaged tissues. Fetal cells have also been shown to infiltrate the mother’s bloodstream, and in experiments with mice these circulating fetal cells have protected pregnant mothers from heart attacks by repairing cardiac tissues.

In addition, the biological effects of chimerism and mosaicism are now becoming apparent in a wide swath of phenomena: from the colored kernels of maize to the variegated patches of the calico cats. Not all the effects are detrimental; indeed, some of the mutations have been shown to be highly beneficial. The most well known example of this is the immune system with its inbuilt antigenic diversity (due to

Recommended Reading:

Mosaicism has also raised its head in the strangest of locales. In a case study reported in the New England Journal of Medicine, when the biological children were tested as possible donors for a mother in need for a kidney transplant, results indicated that two of her three children were not hers! This was due to the fact that the mother had originated from two For a long time clinicians had ascribed a range of genomes, one genome gave rise to her blood clinical disorders (the most prominent being cancer) whereas the other to her eggs. to mosaicism; however, they have not had the tools to Now, researchers are actively studying mosaicism identify and quantify the mosaicism. Recent advances and chimerism more systematically in various facets in genomic technologies including next-generation of human physiology, behavior, aging and disease: sequencing and single nucleotide polymorphism why does one identical twin turn out to be Dr. Jekyll (SNP) microarrays have allowed scientists to look and the other Mr. Hyde, why do women have Y closely at both somatic (body) and germ-line chromosomes in their neurons, where indeed do the mosaicism and chimerism (individual multiple cell seeds of alcohol dependency lie? lineages derived from distinct fertilized eggs). Now a number of diseases have been specifically linked to The results of this research are likely to have far mosaicism and chimerism: neurological disorders ranging effects in science, forensics, geriatric such as autism and Alzheimer’s, muscle disorders research, business, politics and even in the field of such as Duchenne muscular dystrophy, and cardiac- philosophy. Much is based on answers to the related maladies such as hypertension. In the broader fundamental question: are we who we think we are? picture, these studies have allowed physicians/ Our genomes, like the great philosophers and clinicians to now plunge into the field of personalized thinkers of our times, seem to indicate otherwise. The medicine; for instance, Luminex recently received US myth that we are individuals with singular unique FDA and European clearance for genotyping assays persona would be soon replaced with the fact that to aid in patient treatment plans. there is a universe within us waiting to be explored. • Rennie, John: How many genomes do you have? (2011 ). • Zimmer, Carl: DNA Double Take. New York Times (201 3). • Lupski, James: Genome Mosaicism-One Human, Multiple Genomes. Science (201 3). • Yu, Neng and others: Disputed maternity leading to identification of tetragametic chimerism. N. Engl. J. Med. (2002). POSTSCRIPTS | VOL 3, NO. 1 9 | NOVEMBER 201 3

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The History of AMWA

This month, many of our members will be heading to Columbus, Ohio, for the 73rd Annual AMWA meeting. Therefore, it is a good time to look at our roots. The year was 1 940, a gallon of gas cost 1 8 cents and the first-class stamp was 3 pennies. Across the pond, the British Isles had a new prime minister, Winston Churchill, and closer to home in Rock Island, Illinois, George B. Lake, MD, together five 5 other physicians founded Mississippi Valley Medical Writers Association (MVMWA). Eight years later Harold Swanberg, MD, proposed that MVMWA become a national organization and name be changed to American Medical Writers Association. Threequarters of a century later, AMWA has 5600 members from the United States and 26 countries across the globe bound by a common purpose of seeking excellence in medical writing and communications.

George B. Lake, MD

Read more about our history here:

• Ross MF, Thompson SC. Seminal Moments in AMWA History: 70 Years of Medical Communication Excellence. AMWA J. 201 0;25(4):1 66-1 67. • Swanberg H. History of the American Medical Writers' Association: (including the Mississippi Valley Medical Editors' Association). 1 965. Published by Society of Academic Achievement, Quincy, Ill. 236 pages. ASIN: B0007HEC7I • Whippen D. Time Travel at the AMWA Conference. AMWA Conference Blog. November 1 6, 201 0. 0/11 /time-travel-at-amwa-conference.html • American Medical Writers Association (AMWA) [website]. • American Medical Writers Association. Wikipedia.

—Editor POSTSCRIPTS | VOL 3, NO. 1 9 | NOVEMBER 201 3

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Monthly newsmagazine of the AMWA Pacific-Southwest Chapter (AMWA PacSW)